Test, drug susceptibility

Type of medical device or related product
General vs. specific use (health condition)
Intended population sex
Level of technical knowledge
Capital
Reusable
Requirements
None
Healthcare unit
EMDN related code(s)
W01020899
THERAPEUTIC DRUG MONITORING - OTHER
GMDN related code(s)
62192
TNF-alpha inhibitor therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) (A collection of reagents and other associated materials intended to be used for the quantitative measurement and therapeutic drug monitoring of a tumour necrosis factor-alpha (TNF-alpha) inhibitor (e.g., infliximab, adalimumab, golimumab and etanercept) in a clinical specimen, using an enzyme immunoassay (EIA) method. The assay is typically used to monitor blood levels of anti-TNF-alpha therapeutics in the treatment of autoimmune conditions such as Crohn's disease, ulcerative colitis and rheumatoid arthritis.)